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Severe IS will be defined according to an approach proposed by Schubert et al. as hospitalization with a primary hospital discharge diagnosis of IS in combination with an OPS (Operationen und Prozedurenschlüssel) code indicating one of the following: intubation, mechanical ventilation or percutaneous endoscopic gastronomy

Risk of intracranial hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) with renal impairment determined by inpatient claims based diagnoses [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]

Risk of fatal bleeding in patients with NVAF (overall population as well as patients with renal impairment) determined by inpatient claims based diagnoses [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]

Fatal bleeding will be defined as hospitalization with a primary hospital discharge diagnoses for bleeding with documented death as reason for hospital discharge or within 30 days after hospital discharge.

Risk of recurrent hospitalizations (in general and for IS/SE) [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]

Risk of Kidney failure determined by inpatient claims based diagnoses [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]

Risk of treatment discontinuation in patients with NVAF (overall population as well as patients with renal impairment) determined by pharmacy claims [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]

Risk of IS, SE, Severe IS and recurrent IS/SE in patient with NVAF determined determined by inpatient claims based diagnoses [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]

Existing real-world studies have provided evidence that novel oral anticoagulants (NOACs) in general and rivaroxaban in particular are more effective and at least as safe as warfarin in non-valvular atrial fibrillation (NVAF) patients with renal impairment. Nevertheless, it is known that clinicians often hesitate to prescribe NOACs to patients with even moderate renal impairment. Therefore, it is important to investigate effectiveness and safety of rivaroxaban and other NOACs compared to vitamin-K antagonists in NVAF patients with renal dysfunction in real life setting.

The primary objectives of this study are to describe the risk of ischemic stroke (IS)/ systemic embolism (SE) and intracranial hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) and renal impairment initiating treatment with individual NOACs (rivaroxaban, apixaban, edoxaban) compared to phenprocoumon.

Detailed Description

Not Provided

Study Type

Observational

Study Design

Observational Model: CohortTime Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

The source population of this study will include all insured members of approximately 64 German statutory health insurances (SHIs) contributing data to the InGef database.

Condition

Atrial Fibrillation

Intervention

Drug: Phenprocoumon

Follow the physician's prescription.

Drug: Apixaban

2.5 mg or 5 mg, twice daily

Drug: Rivaroxaban (Xarelto, BAY59-7939)

15 mg or 20 mg, once daily

Drug: Edoxaban

30 mg or 60 mg, once daily

Study Groups/Cohorts

Phenprocoumon

Patients with NVAF who initiated the treatment of Phenprocoumon.

Intervention: Drug: Phenprocoumon

Apixaban

Patients with NVAF who initiated the treatment of Apixaban.

Intervention: Drug: Apixaban

Rivaroxaban (Xarelto, BAY59-7939)

Patients with NVAF who initiated the treatment of Rivaroxaban.

Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)

Edoxaban

Patients with NVAF who initiated the treatment of Edoxaban.

Intervention: Drug: Edoxaban

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

First NOAC (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription (index drug) in the enrollment period between 1st January 2013 to 30th June 2017 (index date).

Age of at least 18 years at index date.

Continuous enrollment in the 12 months before the first NOAC (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription in the enrollment period (baseline period).

A verified ambulatory or primary/ secondary hospital discharge diagnosis of NVAF in the 12 months before the first NOAC (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription in the enrollment period (baseline period).